Imager II 5F (angiographic catheters)

2020: A withdrawal of the rejected batch

In the middle of April, 2020 Boston Scientific withdraws 6,130 angiographic catheters of Imager II 5F as there is a probability of detachment of a tip of a catheter during the procedure or in a set-up time to the procedure.

Boston Scientific received a number of the messages concerning the rejected catheters. Not less than nine people were traumatized because of a faulty tip of a catheter of Imager II 5F. The company initiated a withdrawal of the rejected devices, and the list included 6,130 catheters which are sold out during the period from July 16, 2018 to November 26, 2019.

Boston Scientific withdraws 6,130 angiographic catheters of Imager II 5F as there is a probability of detachment of a tip of a catheter during the procedure or in a set-up time to the procedure

Angiographic catheters are used for delivery of contrast substances in blood vessels at an angiography, including in carotids. According to the notification of regulatory bodies, use of the rejected device can become the reason of additional surgical intervention for the purpose of removal of the come-off catheter tip from a blood vessel of the patient. In that case time of stay of the patient in hospital will naturally increase. The Food and Drug Administration (FDA) also does not exclude the probability of the serious undesirable phenomena, including obstruction of a blood-groove (embolism), a stroke or death.

All rejected devices from hospital stock asked to withdraw clients, to immediately stop use of devices with batch number specified in the notification and whenever possible to return them to the company. At emergence of questions concerning the notification, clients can contact the local sales representative or contact the address BSCFieldActionCenter@bsci.com. Besides, health workers and patients can announce the adverse phenomena or problems which they faced when using these devices, through MedWatch — the program for informing on the undesirable phenomena online, a regular mail or by fax.^[1]

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